Country: United States
Language: English
Source: NLM (National Library of Medicine)
DANAZOL (UNII: N29QWW3BUO) (DANAZOL - UNII:N29QWW3BUO)
AvKARE
DANAZOL
DANAZOL 200 mg
ORAL
PRESCRIPTION DRUG
Danazol capsules USP are indicated for the treatment of endometriosis amenable to hormonal management. Most cases of symptomatic fibrocystic breast disease may be treated by simple measures (e.g., padded brassieres and analgesics). In infrequent patients, symptoms of pain and tenderness may be severe enough to warrant treatment by suppression of ovarian function. Danazol capsules USP are usually effective in decreasing nodularity, pain, and tenderness. It should be stressed to the patient that this treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy. Danazol capsules USP are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females. Danazol should not be administered to patients with: - Undiagnosed abnormal genital bleeding. - Markedly impaired hepatic, renal, or cardiac function. - Pregnancy. (See WARNINGS .) - Breastfe
Danazol capsules USP are available as follows: Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. A 01/12 AV 02/16 (P)
Abbreviated New Drug Application
DANAZOL- DANAZOL CAPSULE AVKARE ---------- DANAZOL CAPSULES USP RX ONLY DESCRIPTION Danazol USP is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol. Chemically, danazol USP is 17α-Pregna-2,4-dien-20-yno [2,3- _d_]-isoxazol-17-ol, which has the following structural formula: Danazol capsules USP for oral administration, contain 50 mg, 100 mg or 200 mg of danazol USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow no. 10, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical glaze, propylene glycol, sodium starch glycolate, stearic acid and titanium dioxide The 50 mg and 100 mg capsule shells also contain FD&C yellow no. 6. The 200 mg capsule shell also contains FD&C red no. 40 and D&C red no. 28. CLINICAL PHARMACOLOGY Danazol suppresses the pituitary-ovarian axis. This suppression is probably a combination of depressed hypothalamic-pituitary response to lowered estrogen production, the alteration of sex steroid metabolism, and interaction of danazol with sex hormone receptors. The only other demonstrable hormonal effect is weak androgenic activity. Danazol depresses the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Recent evidence suggests a direct inhibitory effect at gonadal sites and a binding of danazol to receptors of gonadal steroids at target organs. In addition, danazol has been shown to significantly decrease IgG, IgM and IgA levels, as well as phospholipid and IgG isotope autoantibodies in patients with endometriosis and associated elevations of autoantibodies, suggesting this could be another mechanism by which it facilitates regression of the disease. In the treatment of endometriosis, danazol alters the normal and ectopic endometrial tissue so that it becomes Read the complete document